The results of a landmark study published in Circulation indicate that Medtronic’s In.pact Admiral drug-coated balloon (DCB) significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg, specifically, the superficial femoral and proximal popliteal arteries.

Patients in the study’s DCB group experienced the highest rate of primary patency and the lowest rate of clinically-driven target lesion revascularisation at 12 months ever reported from a study of interventional treatments for this common form of peripheral artery disease.

In their conclusion, the authors of the article state that the In.pact Admiral DCB “stands to become an important treatment option for patients with superficial femoral and popliteal artery disease,” which affects millions of people worldwide.

The In.pact Admiral DCB received the CE mark in 2009 but remains an investigational medical device in the USA, where it is under review by the US Food and Drug Administration (FDA). Outside the United States, the device has been used to treat peripheral artery disease in nearly 100,000 patients – more than any other DCB.

The In.pact SFA trial enrolled 331 subjects at 57 sites across Europe and the USA. All study subjects were randomised to treatment with the DCB or standard balloon angioplasty. On the key endpoints:

The clinically driven target lesion revascularisation (CD-TLR) rates at 12 months were 2.4% for the DCB group and 20.6% for the PTA group (p<0.001), a highly statistically significant difference. CD-TLR accounts for repeat procedures, or reinterventions, due to recurrent symptoms related to the treated lesion.

Primary patency rates were assessed at 12 months of follow-up and showed a highly statistically significant difference of 82.2% for the DCB group and 52.4% for the PTA group (p<0.001). Presented at the Charing Cross international symposium in April, the Kaplan-Meier survival estimates for primary patency at Day 360 were 89.8% for the DCB group and 66.8% for the PTA group. Primary patency means a sustained restoration of adequate blood flow through the treated segment of the diseased artery.

“In this trial, the In.pact Admiral drug-coated balloon resulted in superior efficacy when compared to a plain angioplasty balloon for the treatment of patients with symptomatic superficial femoral and/or proximal popliteal” artery disease, the authors report. “There was significantly better primary patency and a marked reduction in the need for target lesion revascularisation at 12 months following treatment with the DCB.”

The researchers also explain why drug-coated balloons represent an “attractive alternative” to other treatments for peripheral artery disease (PAD): “Use of DCB (and avoidance of stent implantation) does not limit future treatment options, an important consideration given the chronic and progressive nature of PAD.”

The article, “Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and/or popliteal peripheral artery disease: 12-month results from the In.pact SFA randomised trial,” by Tepe et al, has been published online and will appear in an upcoming print issue of Circulation.